Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom
NiQuitin patches relieve and/or prevent craving and nicotine withdrawal symptoms associated with tobacco dependence. They are indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
NiQuitin patches are indicated in pregnant and lactating women making a quit attempt.
If possible, when stopping smoking, NiQuitin patches should be used in conjunction with a behavioural support programme.
NiQuitin patches should be applied once a day, at the same time each day and preferably soon after waking, to a different non-hairy, clean, dry skin site and worn continuously for 24 hours.
The NiQuitin patch should be applied promptly on removal from its protective sachet. It should be pressed firmly on the skin with the palm of hand for 10 seconds. Areas where the skin creases should be avoided.
Avoid applying to any skin which is broken, red or irritated. After 24 hours the used patch should be removed and a new patch applied to a fresh skin site. The patch should not be left on for longer than 24 hours. Skin sites should not be reused for at least seven days. Only one patch should be worn at a time.
The patch should be kept sealed in its protective sachet until ready to use. The user should wash hands with water after handling the patch, and avoid contact with eyes and nose.
Patches may be removed before going to bed if desired. However use for 24 hours is recommended to optimise the effect against morning cravings.
Water will not harm the nicotine transdermal patch, if it has been applied properly. The user can bathe, swim or shower for short periods while wearing the nicotine transdermal patch.
Concurrent behavioural support is recommended, as such programmes have been shown to be beneficial for smoking cessation.
During a quit attempt every effort should be made to stop smoking with NiQuitin patches.
NiQuitin therapy should usually begin with NiQuitin 21 mg and be reduced according to the following dosing schedule:
| Dose | Duration |
|---|---|
| Step 1 NiQuitin 21 mg | First 6 weeks |
| Step 2 NiQuitin 14 mg | Next 2 weeks |
| Step 3 NiQuitin 7 mg | Last 2 weeks |
Light smokers (e.g. those who smoke less than 10 cigarettes per day) are recommended to start at Step 2 (14 mg) for 6 weeks and decrease the dose to NiQuitin 7 mg for the final 2 weeks.
Patients on NiQuitin 21 mg who experience excessive side-effects (please refer to precautions), which do not resolve within a few days, should change to NiQuitin 14mg. This strength should then be continued for the remainder of the 6 week course before stepping down to NiQuitin 7mg for two weeks. If the symptoms persist the patient should be advised to seek the advice of a healthcare professional.
For optimum results, the 10 week treatment course (8 weeks for light smokers or patients who have reduced strength as above), should be completed in full. Treatment with NiQuitin patch may be continued beyond 10 weeks if needed to stay cigarette free, however, those who have quit smoking but are having difficulty discontinuing using the patches recommended to seek additional help and advice from a healthcare professional.
Further courses may be used at a later time, for NiQuitin patch users who continue or resume smoking.
For smokers who are unwilling or unable to quit abruptly.
The 21 mg patch can be used daily for 2-4 weeks while the user continues to smoke as needed. At the end of the 2-4 weeks the user should quit completely and continue using Step 1 21 mg patch for 6 weeks daily without smoking. Thereafter following the Step 2 and 3 directions for abrupt cessation above. Should the patient feel able to quit completely before their designated quit date they can do so.
For smokers who wish to cut down with no immediate plans to quit.
A patch can be used while the user continues to smoke as needed. The user should reduce the number of cigarettes smoked as far as possible and to refrain from smoking as long as possible. Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Apply a patch to control troublesome withdrawal symptoms including craving during the period when smoking is being avoided. Users should be encouraged to stop smoking completely as soon as possible.
If users are still feeling the need to use the patches on a regular basis 6 months after the start of treatment and have still been unable to undertake a permanent quit attempt, then it is recommended to seek additional help and advice from a healthcare professional.
Adolescents (12 to 17 years) should follow the schedule of treatment for abrupt cessation of smoking as given above. Where adolescents are not ready or not able to stop smoking abruptly, advice from a healthcare professional should be sought.
Safety and effectiveness in children who smoke has not been evaluated. NiQuitin is not recommended for use in children under 12 years of age.
The minimum lethal dose of nicotine in a non tolerant man has been estimated to be 40 to 60 mg. Even small quantities of nicotine may be dangerous in children and may prove fatal. Suspected nicotine poisoning in a child should be considered a medical emergency and treated immediately.
Signs and symptoms of an overdose from a nicotine patch would be expected to be the same as those of acute nicotine poisoning, including pallor, cold sweat, salivation, nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, disturbed hearing and vision, tremor, mental confusion and weakness. Prostration, hypotension, respiratory failure, rapid or weak or irregular pulse, circulatory collapse and convulsions (including terminal convulsions) may ensue with large overdoses.
The nicotine patch(es) should be removed immediately in the event of an overdose or if the patient shows signs of overdosage. The user should seek medical attention immediately. The skin surface may be flushed with water and dried. No soap should be used since it may increase nicotine absorption. Nicotine will continue to be delivered into the bloodstream for several hours after removal of the system because of a depot of nicotine in the skin.
All nicotine intake should stop immediately. The patient should seek medical attention immediately and be treated symptomatically.
Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastrointestinal absorption of nicotine.
3 years.
Store below 30°C.
7 or 14 patches in a carton. Each patch is contained in a laminate sachet.
Nicotine residues in the used patches are a hazard to children and pets. Used patches should be folded, sticky sides together, put back in the empty sachet or in a piece of aluminum foil and disposed of in accordance with local requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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